Design Assurance Engineer

Reference Number: 050818BM MAIP
Location: MA

Position:  Senior Design Assurance Engineer

Location:  MA

 

Description:

Responsible for contributing to the design, development and management of projects for legacy products and support

of new products under development, with a focus on Design Quality and Compliance activities. 

 

 

• Conduct product design control activities for new and sustaining product development efforts

• Support risk analysis activities, including design and process FMEA

• Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities

• Support Manufacturing Engineering in the creation of DMR, DHR, routers, bills of material, and specifications

for in- house / external manufacturing

• Conduct Internal Audits of the Quality System

• Interact with third-party test houses that conduct testing of company products

• Prepare for and participate in audits by external organizations, such as FDA, ISO etc.

• Perform all other essential duties as assigned

 

Experience Desired:

• Over 5 years of experience with Class II/III electro-mechanical medical device field

• In-depth knowledge of Design Controls, Risk Management practices, Corrective and Preventative Actions,

and regulatory requirements, such as FDA QSR's, ISO 13485, ISO 14971, I.S EN 62366, & ISO 11135, is essential

• Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability,

tolerance interval analysis, power and sample size determinations, etc.), including statistical software tools,

such as Minitab, is preferred

• Experience with supporting medical device compliance testing (e.g. EMC, EMI, IEC)

• Experience with lasers and optical technologies desired, but not necessary

 

Education Required:

• Bachelor's Degree in electrical engineering or similar engineering field

 

 

 

 

Brian Murray

bmurray@photonicsgrp.com

919-572-2292

The Photonics Group

Research Triangle Park, Durham NC